Recall Z-0989-03 ยท INX Bed, Air Fluidized
Hill-Rom Manufacturing, Inc.
CLINITRON CII Air Fluidized Therapy unit.
| Date | Jul 10, 2003 (initiated May 5, 2003) |
| Status | Terminated |
| Reason | Malfunction of side-rail latching pin coupled with inadequate directions for use. |
| Root cause | Other |
| Action | Consignees were notified by letter sent via Airborne express, on May 5, 2003. Side-rail latching pins will be replaced with a more robust version. Label indicating directions for use will be modified to include detailed information on proper procedures for moving the units. |
| Quantity | 122 units (including both units) |
| Distribution | The units are primarily leased to hospitals. Units have been sold to hospitals located nationwide and to Canada, Austria, France, Germany Ireland Italy, Netherlands, Spain, Sweden, Switzerland and the United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K813584 | CLINITRON AIR FLUIDIZED SUPPORT SYSTEM Uhi Corp., Jan 12, 1982 |